Rushmitha, B.A. LL.B., (Hons)., LLM, (Department of Intellectual Property Law) TNDALU, School of Excellence in Law, The Tamilnadu Dr. Ambedkar Law University (School of Excellence in Law)
ABSTRACT
The product of nature doctrine plays a crucial role in determining the patentability of genetic materials and biotechnological innovations, particularly in the context of advanced gene-editing technologies like CRISPR-Cas9. This doctrine asserts that natural phenomena, including naturally occurring genes and genetic sequences, cannot be patented, as they are products of nature. However, the emergence of CRISPR technology has blurred the lines between natural and synthetic, leading to complex legal and ethical challenges surrounding the patenting of isolated DNA sequences and genetically modified organisms. This abstract explores the implications of the product of nature doctrine as it pertains to CRISPR-Cas9, emphasizing the need for clarity in patent laws to accommodate innovations that arise from significant human intervention. Furthermore, ethical issues, including concerns over unintended genetic consequences, social inequality, and the potential for eugenics, are examined. The ethical considerations surrounding the use of CRISPR for germline editing raise questions about individual autonomy, consent, and the long-term impacts on future generations. As CRISPR technology continues to advance, it is imperative to navigate the intersection of legal frameworks and ethical standards thoughtfully. Establishing comprehensive guidelines that address both patentability and ethical implications will be essential for fostering responsible innovation while safeguarding public health and social equity. This exploration underscores the urgency of engaging diverse stakeholders in dialogue and developing frameworks that balance scientific progress with ethical responsibility.
Keywords: Genetic Materials, Biotechnological Innovations, CRISPR- Cas9 Patents, Human Intervention in Biotechnology, Genetic Engineering Innovation.
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